The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, ...

City of Hope®, one of the largest and most advanced cancer research and treatment organizations in the United States and a ...

Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...

The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...

On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), ...

The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.

The study included 2 treatment periods. During the first period, study participants (N=479) were randomly assigned 1:1 to receive denosumab-bmwo or the reference product. Patients who received the ...

Researchers predicted the likelihood of achieving target T-scores in postmenopausal women with osteoporosis who received denosumab therapy for 10 years.

The study explores whether denosumab, a widely used therapy for osteoporosis and bone tumors, can regenerate beta cells, which produce insulin City of Hope, one of the largest and most advanced ...

Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...

The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for ...

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